Recall archive / FDA device enforcement
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292 — FDA record Z-0777-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 9, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
- Reason
- Sterility of Ultrasound gel can not be guaranteed.
- Classification
- Class II
- Recalling firm
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
- Quantity
- 4,923,471
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0777-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 31, 2024
- Recall initiation date
- Jun 9, 2023
- Center classification date
- Jan 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.